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  5. Accelerated Analytical Laboratories Inc. - 534585 - 10/18/2017
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Accelerated Analytical Laboratories Inc. MARCS-CMS 534585 —

Delivery Method:

Recipient Name
David A. Metzger
Accelerated Analytical Laboratories Inc.

9075 W. Heather Ave.
Milwaukee, WI 53224-2411
United States

Issuing Office:
Detroit District Office

United States



Black HHS-Blue FDA Logo


Division of Pharmaceutical Quality Operations III
300 River Place, Suite 5900
Detroit, MI 48207
Telephone: (313) 393-8100
Fax: (313) 393-8139 



October 18, 2017
Case# 534585
David A. Metzger
Accelerated Analytical Laboratories, Inc.
9075 W. Heather Ave.
Milwaukee, WI 53224-2411
Dear Mr. Metzger:
The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Accelerated Analytical Laboratories, Inc. at 9075 W. Heather Avenue, Milwaukee, Wisconsin, from May 8 to 12, 2017.
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See Title 21, Code of Federal Regulations (21 CFR) Part 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
We reviewed your May 25, 2017, response in detail.
During our inspection, our investigator observed specific violations including, but not limited to, the following.
Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).
You conduct laboratory testing on over-the-counter (OTC) drug products manufactured by your clients. You perform both analytical and microbiological analysis for drug release purposes, and these activities are manufacturing operations subject to CGMP. During our inspection of your contract testing laboratory, we observed that you used laboratory methods that were not validated and suitable for their intended uses.
1.    Microbial recovery test method for presence of objectionable organisms in oral rinse
You analyze samples of (b)(4) oral rinse for (b)(4) for the presence of (b)(4), an objectionable microorganism.Your firm’s Microbial Recovery Validation Report (Protocol AAL-16-10) lacks evidence that your test method for the presence of (b)(4) in (b)(4) oral rinse could reliably recover small numbers of microorganisms, including injured or stressed bacteria. You conducted your validation for the test method using (b)(4) instead of stressed organisms. Stressed organisms may be present in drug products at low levels and are often difficult to detect. Accordingly, validation of microbial recovery methods for use on pharmaceutical products should include the use of stressed organisms.
In your response you stated, “we will engage the client (sponsor) of the validation…If the client refuses to revisit and/or sponsor these activities, we will ensure the reports issued for the products examined in ‘Protocol AAL-16-10’ will be updated to note that the testing was done using unvalidated methodology.”
2.    Bioburden analyses for water used in the manufacture of drug products
You also analyze water samples for (b)(4), for bioburden analysis, including for the presence of (b)(4). This water is used as a component in (b)(4) oral rinse. You used the (b)(4) method to analyze water samples for your client. However, this method was not validated for use.
According to your response, you submitted a validation protocol to your client for review and approval. Similar to your response regarding your failure to validate your microbial recovery test method for objectionable organisms, you indicated, “If the client refuses to sponsor these activities we will ensure the reports issued for the products examined in (b)(4) will be updated to note that the testing was done using unvalidated methodology.”
Your response is inadequate. Including a disclaimer on the reports you issue to your customers does not release you from the CGMP requirement that your test methods be validated and suitable for their intended use.
A contract testing laboratory must use validated methods to ensure that results of pharmaceutical analyses subject to CGMP are accurate. Your client’s certificates of analysis (CoA) reported that released drugs conformed to specifications, including microbiological specifications. Your use of test methods that were not validated as suitable for their intended uses compromised the accuracy and veracity of the information your customers provided on their CoA, and on which they relied to make release decisions.
Further, your response did not include your plans to inform your customers that your method validation packages failed to meet CGMP requirements.
In response to this letter, provide the following:
  • The results of a thorough retrospective investigation of all drug testing you have performed for your clients using unvalidated or unverified methods. You should include in this investigation any of your clients’ drugs that are within expiry; and
  • Your plans to inform your clients of the results of this investigation, including your plans to invalidate prior test results based on unvalidated or unverified methods, your plans to validate or verify any previously unvalidated or unverified methods, and plans to discontinue analysis using such methods until such time as you or the client conduct complete and adequate method validation or verification.                                                                                                                     
Responsibilities of contract testing lab
FDA considers contractors as extensions of the manufacturer’s own facility. Your failure to comply with CGMP may affect the quality, safety, and efficacy of the drugs you test for your clients. It is your responsibility to operate in full compliance with CGMP, and to inform all of your customers of significant problems encountered during the testing of these drugs.  
The violation cited in this letter is not intended as an all-inclusive list. You are responsible for investigating this violation, for determining the cause, for preventing recurrence, and for preventing other violations.
Correct the violation cited in this letter promptly. Failure to promptly correct this violation may result in legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.
Until this violation is corrected, we may withhold approval of pending drug applications listing your facility. We may re-inspect to verify that you have completed your corrective actions.
After you receive this letter, respond to this office in writing within fifteen (15) working days. Specify what you have done since our inspection to correct your violation and to prevent recurrence. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Please send your electronic reply to: ORAPHARM3_RESPONSES@fda.hhs.gov.
            Attn:    Brian D. Garthwaite, Ph.D., Compliance Officer
                        U. S. Food and Drug Administration
                        Division of Pharmaceutical Quality Operations III
Refer to the Unique Identification Number (Case# 534585) when replying. If you have questions regarding the contents of this letter, please contact Dr. Garthwaite by phone at (612) 758-7132.
Art O. Czabaniuk
Program Division Director
Division of Pharmaceutical Quality Operations III


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