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Annual Product Quality Review
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Written procedures are not followed for evaluations conducted to review records associated with batches Carma Laboratories, Inc. |
14 Nov 2023 | Normal | Justification: The deficiencies in conducting and closing APRs directly fall under Annual Product Quality Review as process type. Excerpt: Specifically, Your firm failed to perform Annual Product Review (APR) for Domestic Lip Balm Stick and Domestic Lip Balm Tube for the year of 2022. According to your written procedure, individual APR are completed (b) (4) . Additionally, your procedure is deficient for the closure of APRs on a timely manner. For example, APR for Domestic Lip Balm Stick review period (1/1/2021 - 12/31/2021) was not completed until 12/29/2022. View Details |
| Failure of your quality unit to perform an annual product review Brenntag Great Lakes, LLC |
05 May 2023 | Normal | Justification: The observation specifically mentions a failure to perform annual product reviews, which directly relates to the 'Annual Product Quality Review' process type. Excerpt: Failure of your quality unit to perform an annual product review. Specifically, Your Quality Unit failed to perform annual product review for the following products. View Details |
| Written procedures are not established for evaluations conducted at least annually to review records associated with a representative number of batches H J Harkins Company Inc dba Pharma Pac |
03 Mar 2023 | Normal | Justification: The observation specifically mentions the lack of annual evaluations, which is a core requirement of Annual Product Quality Review. Excerpt: Your firm has not conducted any annual evaluations for the products you repack. View Details |
| Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches Sina Health Inc |
13 Jan 2023 | Normal | Justification: Annual Product Quality Review is directly linked since the observation indicates a failure to conduct required annual evaluations. Excerpt: Your firm has not completed (b) (4) evaluations from 2017-2021. View Details |
| The responsibilities and procedures applicable to the quality control unit are not fully followed Orly International, Inc. |
20 Dec 2022 | Normal | Justification: Annual product quality review ensures continuous product suitability and quality consistency. Excerpt: Your firm does not perform annual product reviews for OTC hand sanitizer and antifungal drug products. View Details |
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