WARNING LETTER
Baldwin Richardson Foods Pennsauken, LLC MARCS-CMS 699022 —
- Delivery Method:
- VIA Electronic Mail
- Product:
- Food & Beverages
- Recipient:
-
Recipient NameErin Tolefree
-
Recipient TitlePresident and CEO
- Baldwin Richardson Foods Pennsauken, LLC
3268 Blue Heron Drive
Macedon, NY 14502
United States
- Issuing Office:
- Human Foods Program
United States
United States
December 26, 2024
WARNING LETTER
Ref: Case # 699022
Dear Ms. Tolefree,
The U.S. Food and Drug Administration (FDA) inspected your aseptic processing facility of low-acid canned food (LACF) non-dairy beverages Baldwin Richardson Foods Pennsauken, LLC located at 1550 John Tipton Boulevard, Pennsauken, New Jersey, from July 15 to August 23, 2024. During our inspection, we found serious violations of the Emergency Permit Control regulation [Title 21, Code of Federal Regulations (CFR) (21 CFR Part 108)], (21 CFR 108), and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation, Title 21 CFR Part 113 (21 CFR 113).
As a manufacturer of LACF products, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act) and the Federal regulations relating to the processing of low-acid foods packaged in hermetically sealed containers. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for thermally processed low-acid foods packaged in hermetically sealed containers whenever a processor has failed to fulfill the requirements of 21 CFR 108.35, including registration and filing of process information, and the mandatory requirements in 21 CFR Part 113. Regulations specific to the processing of LACF products are described in 21 CFR Part 108 and 21 CFR Part 113. As outlined in these regulations, a commercial processor that does not adhere to all the mandatory requirements of 21 CFR 108.35 and 21 CFR Part 113 could be subjected to an immediate application of the emergency permit control provisions of section 404 of the Act (21 U.S.C. § 344). Violation of the mandatory requirements set forth in 21 CFR 108.35 and 21 CFR Part 113 renders your low acid products adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4). You can find the Act and LACF regulations through links in FDA’s home page at www.fda.gov.
At the conclusion of the inspection, FDA investigators issued a Form FDA 483 (FDA-483), Inspectional Observations, that listed the serious violations observed at your firm. You provided a written response to the inspectional findings on September 22, 2024, describing corrective actions planned by your firm. After reviewing the inspectional findings and the responses that your firm provided, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. We also address your response in part below.
Your significant violations are as follows:
1. You must identify and evaluate deviations from the scheduled process or critical factors, which are out of control and follow your competent processing authority’s recommended procedures to determine that no significant potential for a public health hazard exists in a lot of products before shipping, as required by 21 CFR 113.89.
On May 17, 2024, you manufactured Califia Toasted Coconut Almond Milk, lot (b)(4). As part of your finished product testing, you incubate finished product for (b)(4) days at (b)(4)F for Bac-T testing. You also incubate finished product for (b)(4) days at (b)(4)F for pH testing, as pH shifts may be the result of microbial contamination. A finished product sample collected on May 17, 2024 (Julian date 4138) at (b)(4), lot (b)(4) found microbiological growth by (b)(4) analysis. Speciation and analysis of the deviation reported (b)(4).” You identified these findings as a process deviation and submitted it for review by your process authority.
In order to confirm commercial sterility, your process authority recommended product stress testing by randomly selecting and incubating (b)(4) samples of the product throughout the entire production run (b)(4) for (b)(4) days at (b)(4)F and measuring product pH. However, you only targeted sampling between (b)(4) and (b)(4) for the lot. In addition, the finished product pH values for lot (b)(4) analyzed on May 24, 2024, ranged from (b)(4), whereas the pH range found during stress testing was (b)(4). You calculated the acceptable pH range based upon the average (b)(4) (from stress test) (b)(4) standard deviations of samples measured on June 20, 2024, to be (b)(4).
Despite these inconsistencies with the recommended sampling and testing protocol and without scientific rationale for the calculated acceptable pH range, your process authority reported the samples passed the pH evaluation and all QA data was within specification. Based upon the results of the product evaluation, your process authority determined that toasted coconut almond milk, lot (b)(4) 48 oz. produced on May 17, 2024, from (b)(4) AM “(b)(4)” Moreover, your process authority’s evaluation did not address the microbial findings of “(b)(4)”, which may be indicative of post-processing contamination or under processing. In your response to this warning letter, you should include your evaluation of the entire production lot to demonstrate that the lot was not under processed nor subject to post-process contamination. In addition, since pH shifts may be indicative of microbial contamination, please provide an explanation for your calculation of an acceptable pH range.
Furthermore, during the filling on May 16 to May 17, 2024, temperature sensor (b)(4) Drying Air Temperature appeared to be consistently recording below (b)(4)C during application of closures for toasted coconut almond milk identified as lot (b)(4). The (b)(4) Drying Air Temperature (b)(4) is identified as a critical factor for your filling process and the critical limit is (b)(4)C. You did not identify these temperature deviations as process deviations.
In your written response, dated September 22, 2024, you state that you will review your deviation system, including updating your process to ensure your process authority’s procedures are followed and that any deviation noted in your (b)(4) Lot Report for aseptic filling will be evaluated by your process authority to ensure commercial sterility of the product. You also state you agreed that the temperature measured by sensor (b)(4) “(b)(4)” You said you will reset the equipment to ensure the temperature complies with the filed critical limit. However, you did not provide a revised procedure for handling process deviations, nor did you provide an evaluation by your process authority to assess the process deviation for the (b)(4) drying air temperature.
2. You must record each entry on the processing and production records at the time the operation occurs, and the processing and production record must be reviewed by a qualified representative of plant management to ensure that the product received the scheduled process within one (1) working day of processing and prior to shipment or release for distribution, as required by 21 CFR 113.100(b).
Our inspection found that your official production records (e.g., hardcopy (legacy) “(b)(4) generated from your (b)(4) software, (b)(4) Lot Reports (“LR”), (b)(4) charts, etc.) for the pre-sterilization process, the processing to commercial sterility, and the maintenance of asepsis of the finished product through packaging lacked documentation of critical factors and an explanation of any deviations from critical factors identified in your filed scheduled process. In addition to not recording some critical factors, our investigators observed that your software did not have set points (upper and lower limits), and other critical parameters established, monitored, and/or alarmed. Therefore, your software could not ensure that critical factors were consistently being achieved, including establishing and maintaining an aseptic product through packaging. Additionally, your firm routinely shipped LACF finished products in commerce prior to reviewing and signing off on records. These records included pH testing results and incubation analysis results for sterility.
Specifically, our investigator reviewed the printed hardcopy (legacy) (b)(4) for 48 oz. plastic containers of shelf-stable toasted coconut almond milk, lot (b)(4) and found the following:
a. You did not record the critical factors for the aseptic processing unit and aseptic surge tank, including the correct hold tube configuration, steam barriers downstream from the hold tube and surge tank during production and sterilization in your legacy (b)(4). For example, the critical factors for the sterilization process of the (b)(4) shaft steam seal, (b)(4), requires “(b)(4)” for “(b)(4)” during “(b)(4) sterilization,” as established by a validation study performed by your process authority. The critical factors for (b)(4) are electronically captured by the (b)(4) temperature transmitter, via computer software. However, the sterilization critical factors were not recorded in the printed hardcopy (b)(4).
b. You did not record the critical factor sterilization times for the (b)(4) sterilization of the aseptic filling unit, including the timers for the sterile water unit, product circuit sterilization, and sterile air filter in your legacy (b)(4) listed. These critical factors are listed in the “(b)(4)” under SID (b)(4) for 48 OZ container of toasted coconut almond milk. For example, after the clean-in-place (CIP) scheduled on May 16, 2024, your firm ran a second sanitation between lots of a continuous production run on May 17, 2024, prior to manufacturing Califia Toasted Coconut Almond Milk, lot (b)(4), and this process was not recorded in your legacy (b)(4). Furthermore, your quality manager and one of your aseptic filling unit operators said the timers were not recorded in the printed hardcopy (b)(4) forms or other forms.
In your written response, you state you will change the process for preparing the (b)(4) so that all critical data is printed in the (b)(4), including but not limited to any comments sections that show how any deviations were addressed and resolved. You state the (b)(4) is continuously monitored in both (b)(4) and (b)(4) during sterilization and production but recorded under a different tag name and you will work with (b)(4) to update the name in your records. You also state all critical factors for the aseptic filler are recorded in the filler (b)(4)” and will be printed after each day’s production. However, you did not provide supporting documentation demonstrating you have implemented the corrective action and that you now have printed hardcopy (legacy) records for the monitoring and review of all critical factors established and listed in your scheduled process and associated SUP-SID. We will verify the adequacy of your response during a future inspection.
c. The (b)(4) LR record was not scaled on the y-axis to read the actual values. For example, the critical factor for the flow rate of the (b)(4) blower (measured by sensor (b)(4)) listed in the “SUP-SID (b)(4)” under SID #(b)(4) for 48 OZ container of toasted coconut almond milk value is greater than or equal to (b)(4) g/hr. However, the scale of the y-axis for the printed hardcopy (b)(4) LR for toasted coconut almond milk lot # (b)(4) has no intermediate marks between (b)(4) and (b)(4) g/hr for sensor (b)(4). The x-axis was also over (b)(4) hours. There were approximately (b)(4) narrow readings that appear as spikes. The timeframe of those spikes could not be determined preventing review of actual critical values recorded.
d. You use an electronic monitoring software, (b)(4), to monitor if critical factors are met during the processing of your aseptic, low-acid beverage. However, your upper and lower set limits for the sensors were not set to ensure the critical factors in the “SUP-SID (b)(4)” under SID #(b)(4) for 48 OZ container of toasted coconut almond milk are met during production and sterilization of the aseptic filling unit. For example, the air flow rates for HEPA filters (b)(4) must be less than or equal to (b)(4) nl/min. In (b)(4) you have only preprogrammed a lower limit of (b)(4) nl/min and no upper limit. Furthermore, only lower limits are preprogrammed for the filed critical factors for the cap sterilization air flow. Your manufacturing records only provide one reading for several hours of production based on the lower limits and your software records this as “Pass.” Without the upper limits for critical parameters programmed into your monitoring software, you are unable to demonstrate that these parameters have been met in accordance with the supplemental submission identifier (SUP SID) that you filed with FDA.
In your written response, you commit to ensure the report complies with the upper and lower critical limits as defined in the filed SUP-SID. Your response also provides an explanation of critical limits and necessary adjustments needed for your monitoring software, but does not include any procedures or records that demonstrate corrections will be implemented. Furthermore, you did not provide any supporting documentation to demonstrate you are printing your critical factors in such a way to determine by review that both the lower and upper set limits are met. We will verify the adequacy of your response during a future inspection.
e. You routinely distributed product in commerce before record review was complete. For example, Califia Toasted Coconut Almond Milk, lot (b)(4), was distributed into commerce between May 18 and 21, 2024. Records reviewed by FDA investigators indicated that your review of the (b)(4) report was not completed until May 23, 2024, review of your pH and incubation results were not completed until May 24, 2024, and your review of the monitoring software data (b)(4) was not complete until June 10, 2024. Our investigators’ review of critical factor records related to the aseptic processing unit, aseptic surge tank, and aseptic filling unit for four (4) additional finished product lots produced between June and July 2024 found that these finished products were also distributed before review and signoff on your (b)(4) forms, (b)(4) charts, incubation records, and pH verification records for commercial sterility. Furthermore, you told FDA investigators that you do not have control of products once they are released and received by your customer.
In your written response you state that all records are reviewed within 24 hours. However, this contradicts the records reviewed during our most recent inspection. For example, a review of the (b)(4) for Califia Toasted Almond Milk, lot (b)(4) referenced above indicates that it was printed on (b)(4) (this appears on the bottom left corner of the printout from (b)(4)). This appears to indicate that the official record was created more than (b)(4) hours after production was complete. You also commit to reviewing, signing and dating your legacy production records prior to releasing product for commercial distribution. We will verify the adequacy of your response during a future inspection.
3. You must maintain regular observations during production runs for gross closure defects and any defects observed and corrective actions taken must be recorded as required by 21 CFR 113.60(a).
During review of the legacy (b)(4) for toasted coconut almond milk, our investigator observed at least six container integrity check failures in torque or pull-up without corrective actions for various lots. Your written procedure, titled (b)(4), states (b)(4) One example includes Califia Toasted Coconut Almond Milk, lot (b)(4), which had a torque value of (b)(4) for bottle code (b)(4).” The monitoring software establishes a lower limit value of (b)(4) for torque. Corrective actions in accordance with your established procedures were not documented in the comments section of your (b)(4) software for this lot. During the inspection your Quality Manager stated that there was a typographic entry to cause the (b)(4) value and since this was entered as a typographic entry, only a consecutive retest was performed with no additional corrective actions taken. Another example is Califia Farms Organic Unsweetened Almond Milk, lot (b)(4), which had a torque value of (b)(4), and during the inspection on July 31, 2024, your Quality Manager verified that there were no corrective actions or other information to address this deviation in the comments section in your (b)(4) software.
In your written response, you indicate that appropriate corrective actions were performed and recorded in the electronic records; however, you did not provide documentation to support your response. You also committed to modify the (b)(4) program to allow the comments and any other relevant information to be printed on the (b)(4) form so that it can be reviewed as part of the official record for the production of your shelf-stable, aseptically packaged low acid products. The adequacy of this corrective action will be verified during a future inspection.
Furthermore, 21 CFR 113.60(a) requires in part that visual examinations for gross closure defects be conducted at intervals of sufficient frequency to ensure proper closure and that such measurements and recordings should be made at intervals not to exceed 30 minutes. A review of records of other lots showed gaps in time when container closure examinations were not documented in records. An example was Califia Farms Toasted Coconut Almond Milk, Lot (b)(4). A container integrity check was performed for bottle code time (b)(4)” and entered to the monitoring software “(b)(4).” The next container integrity check was performed at bottle code time “(b)(4)” and entered into the monitoring software “(b)(4).” There were at least three hours during which container integrity checks were not documented.
Your written response to this observation states that the gaps in recording container integrity checks were caused by downtimes in filling. However, you did not present production records that demonstrate that there were gaps in manufacturing at these times.
4. You must observe and record proper performance of the steam seals at the start of aseptic packaging operations and at intervals of sufficient frequency to ensure that these values are as specified in the scheduled process, as required by 21 CFR 113.40(g)(1)(ii)(E). You were not observing and recording the proper performance of the steam seals downstream of the hold tube, including the divert valve steam trap temperatures (TSL 164, 165, and 180), UHT & Alsafe steam barrier temperature (b)(4), divert valve cluster steam barrier (b)(4), and the sterile homogenizers (b)(4). The performance of steam seals for equipment downstream from the holding tube should be monitored and recorded during operations to ensure aseptic conditions are maintained through filling and packaging due to the potential for entry of microorganisms.
In your written response, you state that the performance of all steam barriers downstream from the hold tube are being monitored in real time, but you did not provide any supporting documentation to demonstrate they are being monitored and recorded. You commit to training your operators to monitor and record these readings and ensure entry of the data into (b)(4). You also state the operator forms will be reviewed and revised to ensure operators are documenting all steam barriers downstream of the hold tube. You did not provide a timeframe for the completion of this corrective action. We will verify the adequacy of the corrective action during a future inspection.
This letter is not intended to be an all-inclusive statement of violations at your facility or in connection with your products. You are responsible for investigating and determining the cause of the violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law including FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure, and injunction. We also remind you that if you do not adhere to all the mandatory requirements of 21 CFR 108.35 and 21 CFR 113, you could be subjected to immediate application of the emergency permit control provisions of section 404 of the Act [21 U.S.C. § 344].
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Victoria Wagoner, Compliance Officer, Office of Compliance and Enforcement, Office of Enforcement, Division of Conventional Foods Enforcement, 5001 Campus Drive, College Park, MD 20740. If you have any questions regarding this letter, you may contact Victoria Wagoner via email at Victoria.Wagoner@fda.hhs.gov. Please reference Case # 699022 on any submissions and within the subject line of any emails to us.
Sincerely,
/S/
Maria S. Knirk, JD MBA
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program