McNeil Healthcare, LLC
Form 483 issued March 31, 2021 · Las Piedras, Puerto Rico
- Inspection
- Mar 31, 2021
- Investigators
- Jose E. Melendez· Jose M. Cayuela
- Observations
- 7
- Pages
- 6
- FEI number
- 2650141
In short: On March 31, 2021, FDA issued a Form 483 with 7 observations to McNeil Healthcare, LLC in Las Piedras, Puerto Rico (FEI 2650141) after an inspection that ran Mar 31, 2021. The investigators were Jose E. Melendez and Jose M. Cayuela. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and quality system account for 5 of 7 observations.
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
Control procedures are not established which monitor the output of those manufacturing processes that may be…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
- 03
Procedures for the eleaving.and maintenance cf equipment are deiiciert regarding…
- 04
Written production and control procedures not followed in the execution of production…
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 7 observations on this Form 483, mostly about production, quality system and facilities & equipment. 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 Jose M. Cayuela are named on this Form 483, for the inspection of Mar 31, 2021. Each investigator has a profile showing what they cite most.
When was McNeil Healthcare, LLC inspected by FDA?
The inspection ran Mar 31, 2021, and the Form 483 is dated March 31, 2021.
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.