McNeil Healthcare, LLC

Form 483 issued January 8, 2010 · Las Piedras, Puerto Rico

Inspection: Oct 22, 2009 – Jan 8, 2010
Investigators: Gonzalez Rivera· Jose R. Lopez
Observations: 7
Pages: 8
FEI number: 2650141

In short: On January 8, 2010, FDA issued a Form 483 with 7 observations to McNeil Healthcare, LLC in Las Piedras, Puerto Rico (FEI 2650141) after an inspection that ran Oct 22, 2009 – Jan 8, 2010. The investigators were Gonzalez Rivera and Jose R. Lopez. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).

At a glance

Quality system and laboratory controls account for 5 of 7 observations.

Quality system3

Laboratory controls2

Facilities & equipment1

Other1

Most cited: 21 CFR 211.192 (2×)

What FDA observed

Preview: the opening words of each observation

01
21 CFR 314.81(b)(1)(ii)
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
02
21 CFR 211.192
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product…
03
21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in…
04
21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…

3 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

Gonzalez Rivera

1 document · 2010

Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.

The firm

McNeil Healthcare, LLC history

All 12 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.192

See how FDA wrote the same problem up elsewhere.

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Questions about this 483

What did FDA find at McNeil Healthcare, LLC?

FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls 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?

Gonzalez Rivera and Jose R. Lopez are named on this Form 483, for the inspection of Oct 22, 2009 – Jan 8, 2010. Each investigator has a profile showing what they cite most.

When was McNeil Healthcare, LLC inspected by FDA?

The inspection ran Oct 22, 2009 – Jan 8, 2010, and the Form 483 is dated January 8, 2010.

How do I get the full Form 483 for McNeil Healthcare, LLC?

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