McNeil Healthcare, LLC
Form 483 issued September 20, 2023 · Las Piedras, Puerto Rico
- Inspection
- Sep 12 – Sep 20, 2023
- Investigators
- Jose E. Melendez· Marian E. Ramirez
- Observations
- 5
- Pages
- 9
- FEI number
- 2650141
In short: On September 20, 2023, FDA issued a Form 483 with 5 observations to McNeil Healthcare, LLC in Las Piedras, Puerto Rico (FEI 2650141) after an inspection that ran Sep 12 – Sep 20, 2023. The investigators were Jose E. Melendez and Marian E. Ramirez. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
3 of 5 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Procedures describing the handling of written and oral complaints related to drug product are…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmMcNeil Healthcare, LLC history
All 12 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at McNeil Healthcare, LLC?
FDA listed 5 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected McNeil Healthcare, LLC?
Jose E. Melendez and Marian E. Ramirez are named on this Form 483, for the inspection of Sep 12 – Sep 20, 2023. Each investigator has a profile showing what they cite most.
When was McNeil Healthcare, LLC inspected by FDA?
The inspection ran Sep 12 – Sep 20, 2023, and the Form 483 is dated September 20, 2023.
How do I get the full Form 483 for McNeil Healthcare, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.