Wockhardt, a Rs. 4, 450 crore plus pharma major, received another blow as the US FDA issued fresh warning letter for significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals, 21 CFR parts 210 and 211 for API at its Bharuch, Ankleshwar facility. The US FDA inspected facility during December 7 to 15, 2016.
FDA has placed Wockhardt on Import Alert 66-40 on August 5, 2016. Until it correct all violations and deviations completely and US FDA confirm the company's compliance with cGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.
Failure to correct these violations and deviations may also result in FDA continuing to refuse admission of articles manufactured at Wockhardt, Plot No. 138 G.I.D.C. Estate District Bharuch, Ankleshwar, Gujarat, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Under the same authority, articles may be subject to refusal of admission, in that the methods and controls used in Wockhardt's manufacture do not appear to conform to cGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).
US FDA's investigator observed specific violations and deviations and pointed out that Wockhardt failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
Further, US FDA said, Wockhardt failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination (21 CFR 211.28(a)). Further, It also failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).
US FDA investigator also found that the company reported only two of three chromatographic injections of sterile (b)(4) batch (b)(4) during in-process (b)(4) sample testing for residual solvent. Wockhardt did not explain why it excluded the third injection. The company decommissioned this instrument in July 2014 without reviewing the instrument data.
Wockhardt failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). The company also failed to record activities at the time they are performed, and destruction of original records.
US FDA said that cGMP documentation was discarded without being assessed by its quality unit. Investigator found torn and shredded equipment maintenance documents, raw material labels, and change control work orders in its scrap yard awaiting incineration. The company staff lacked knowledge of its corporate procedure for the destruction and incineration of documents.
wockhardt's quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufacture. US FDA strongly recommend that Wockhardt retain a qualified consultant to assist in its remediation.
Violations and deviations cited in this letter are not intended as an all-inclusive list. The letter pointed out that the company is responsible for investigating these violations and deviations, for determining the causes, for preventing their recurrence, and for preventing other violations and deviations in all your facilities.