Recipient: Amsino Medical
Product: sodium chloride and heparin catheter lock-flush solutions
Date: 4/3/09
This inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act (21 U.S.C., Section 351(h)), because the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation do not conform with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations, Part 820 ( 21 CFR 820). We received a response letter, with enclosures from (b)(7)(c), dated November 4, 2008, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations (483) issued to (b)(7)(c). We received a response update, dated February 10, 2009, from (b)(7)(c) which supplied additional information and updated versions of some documents. We address the responses below, in relation to each of the noted violations. The violations include, but are not limited to, the following:
2. Failure to adequately ensure all corrective and preventive action activities required under 21 CFR 820.100, and their results, are documented, as required by 21 CFR 820.100(b).
For example, your firm failed to complete a (b)(4) for changes to the which your firm reprogrammed on August 9-10, 2008. This software was placed into production by your firm on August 11, 2008.
Your response to this observation appears to be adequate.
3. Failure to adequately validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i).
For example, your firm failed to provide documentation detailing the validation of the (b)(4) and (b)(4) prior to production use. (b)(4) on both systems were reprogrammed on August 9-10, 2008, and utilized in production on August 11, 2008. The validation was not completed until October 6, 2008.
Your response to this observation appears to be adequate.
FDA New Orleans District Office
