- SuperValue, Inc.
- Issuing Office:
- Philadelphia District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||PHILADELPHIA DISTRICT|
900 U .S. Customhouse
2nd and Chestnut Streets
Philadelphia. PA 19106
VIA United Parcel Service
September 20, 2016
Ms. Beth Kroutch, General Manager
500 South Muddy Creek Road
Denver, PA 17517
Dear Ms. Kroutch:
We inspected your seafood processing facility, located at 500 South Muddy Creek Road, Denver, PA, between the following dates: August 10 and 19, 2016. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)]. Accordingly, your refrigerated seafood products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulations, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov
We received your response letter on September 6, 2016 concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations that was issued to your firm. We address this response below, in relation to each of the noted violations.
Your significant violations are as follows:
1) You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control pathogenic bacterial growth or toxin formation when your process for storing seafood products deviated from your critical limit at the CCP2 Storage (Temporary Trailer Storage) critical control point. Your HACCP plan titled “Seafood HACCP Plan” dated 6/16/16 indicates a critical limit of (b)(4) with monitoring of (b)(4). The investigator documented 21 instances of temperatures above (b)(4) between June 2, 2016 and August 10, 2016. No corrective actions were documented in any of these instances.
Your response to this observation is not adequate. You state that you have conducted your own examination of how product temperatures responded to fluctuations in ambient temperatures and you have determined that product temperatures are significantly less variable than ambient temperatures, however no evidence of this testing was provided. You also state that you have conducted formal training with individuals responsible for temperature monitoring; no evidence of this training has been provided to date. We acknowledge that you have revised the CCP2 (Temporary Storage Trailer) critical limit of your “Seafood HACCP Plan” signed 9/6/16, however it remains inadequate for controlling pathogenic bacterial growth or toxin formation. Please refer to point 3) in this letter.
2) You must have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.”
Your firm’s “Seafood HACCP Plan” signed 9/6/16 submitted in your FDA 483 response does not list the food safety hazard of allergens.
3) You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.”
Your response to this observation is not adequate. Your firm’s “Seafood HACCP Plan” signed 9/6/16 does not list an adequate critical limit for your CCP1 (Receiving) critical control point. For example, the plan does not distinguish between ambient and internal temperatures, nor does it address the product’s time in transit. We acknowledge that you have revised your “Seafood HACCP Plan” to designate the critical limit at CCP2 Storage (Inside DC) and CCP2 (Temporary Trailer Storage) to (b)(4).
4) You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm’s HACCP plan for seafood lists a monitoring procedure at the CCP1 (Receiving) critical control point that is not adequate to control pathogenic bacterial growth or toxin formation.
For example, your “Seafood HACCP Plan” signed 9/6/16 does not address your monitoring of the adequacy of ice, the date and time seafood was removed from a controlled temperature environment, date and time of delivery, internal temperature of the product, or review of carrier records.
5) Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). Your corrective action plan for seafood at the CCP1 (Receiving) critical control point to control pathogenic bacterial growth and toxin formation is not appropriate.
Your “Seafood HACCP Plan” signed 9/6/16 states that the corrective action at this critical control point will include the rejection of the lot, then “supplier informed to prevent further occurrences.” This is not adequate. FDA recommends that firms discontinue use of the supplier/carrier until evidence is obtained that the identified transportation handling practices have been corrected.
6) You must monitor the conditions and practices during processing with sufficient frequency to ensure conformance with current Good Manufacturing Practices, as required by 21 CFR 123.11(b). During the recent inspection at your firm, the investigator observed greater than one-inch gaps in 19 of 85 loading bay doors in your Ambient and Refrigerated Receiving/Distribution areas, which lead directly to your Ambient and Refrigerated warehouse areas.
We acknowledge your response dated 9/6/16 stating that repairs have been made to these doors. This correction will be verified during a subsequent inspection of your firm.
We suggest that you use the Fish & Fisheries Products Hazards & Controls Guidance: Fourth Edition to evaluate your firm’s operation regarding seafood products. While the guidance is not a binding set of requirements, it does provide information that will most likely result in a HACCP plan that is acceptable to FDA. Firms may choose other control measures, but they are then responsible for scientifically establishing their adequacy.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm complies with the Act, the seafood HACCP regulations (21 CFR Part 123), the Current Good Manufacturing Practice regulations (21 CFR Part 110), and the Food Labeling regulations (21 CFR Part 101). You should take prompt action to correct these violations. Failure to correct these violations in a prompt manner may result in regulatory actions without further notice, such as seizure, injunction, and/or prosecution.
Additionally, the inspection referenced above identified violations materially related to the food safety requirements of the Act. Accordingly, Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs associated with reinspection. A reinspection is one or more inspections conducted following an inspection that identified noncompliance materially related to the food safety requirements of the Act, specifically to determine whether compliance has been achieved. Reinspection costs include all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees. FDA will assess and collect fees associated with this reinspection in accordance with Section 743 of the Act.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct these violations. Your response should include your revised HACCP plans and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your written response should be sent to Robin M. Rivers, Compliance Officer at the address noted above. If you have questions regarding any issues in this letter, please contact Compliance Officer Rivers at (215) 717-3076 or email@example.com.
Anne E. Johnson
cc: Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Director