# FDA 483 - McNeil Healthcare, LLC - January 08, 2010

Source: https://www.keypedia.com/records/483/mcneil-healthcare-llc/961bbc65-047d-4c08-b4b1-b90329a6d60c

> FDA 483 for McNeil Healthcare, LLC on January 08, 2010. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: McNeil Healthcare, LLC
- Inspection Date: 2010-01-08
- Product Type: Drugs
- Office Name: San Juan District Office
- Summary: The FDA inspected McNeil Healthcare, LLC, a drug manufacturer in Las Piedras, PR, from October 22, 2009, to January 8, 2010. This inspection resulted in an FDA 483, identifying multiple significant deviations from Current Good Manufacturing Practices (CGMP) concerning the company’s quality, production, and laboratory control systems.Primary issues included critical delays in submitting Field Alert Reports for Tylenol Arthritis Relief Caplets (TAR) affected by a musty odor, despite numerous consumer complaints and associated adverse events. The company's investigations into such product discrepancies, including the musty odor and dissolution failures in Motrin, were inadequate, often failing to thoroughly assess other affected batches or products and identify root causes. The quality control unit demonstrated a systemic failure to follow procedures for management notification and complaint handling, leading to delayed trend detection and insufficient investigation conclusions, particularly for recurring product mix-ups.Moreover, the firm neglected to investigate significant manufacturing process deviations, such as extended downtimes during Motrin production, and recurrent laboratory contamination issues impacting product assays. In the production area, inadequate cleaning and maintenance procedures were evident, contributing to a pattern of product mix-ups that were not effectively addressed. Laboratory controls were deficient, lacking scientific justification for certain specifications and appropriate stability testing methods for Tylenol Arthritis Caplets. Additionally, laboratory records were incomplete, missing necessary reviews, raw data, and validation for analytical methods used.McNeil Healthcare, LLC, is now required to provide a comprehensive written response to the FDA, outlining specific corrective and preventive actions for each observation to ensure full compliance with drug manufacturing regulations.

## Related Documents

- [483 - 2010-01-08](https://www.keypedia.com/records/483/mcneil-healthcare-llc/f7c149ef-730a-40e5-a18b-d93ca4657393)
- [WARNING_LETTER_RESPONSE - 2010-01-08](https://www.keypedia.com/records/warning_letter_response/mcneil-healthcare-llc/6538196e-f861-4245-81af-c6383519bd14)
- [483_RESPONSE - 2010-01-08](https://www.keypedia.com/records/483_response/mcneil-healthcare-llc/58baa274-e0a9-453e-901d-c96e5633a13f)
- [483 - 2008-08-06](https://www.keypedia.com/records/483/mcneil-healthcare-llc/d00de07d-41c4-40e7-90e0-63c8d79850b0)
- [483 - 2002-09-09](https://www.keypedia.com/records/483/mcneil-healthcare-llc/70f8e191-afb3-410a-a22c-aa9d2942d86a)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/raquel-gonzalez-rivera/84cdd41f-b03c-4d13-a289-e2ebf4417c3c)
- [Program Expert](https://www.keypedia.com/people/jose-r-lopez/90b67bee-f6bc-4d47-9949-fa96f3aae85d)

Company: https://www.keypedia.com/companies/mcneil-healthcare-llc/5f388817-1e62-4133-bd19-17b205bff73c

Office: https://www.keypedia.com/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8