Johnson and Johnson (McNeil)
Form 483 issued July 9, 2010 · Lancaster, Pennsylvania
- Inspection
- Jun 22 – Jul 9, 2010
- Investigators
- Anita R. Michael· Sharon K. Thoma
- Observations
- 12
- Pages
- 12
- FEI number
- 1000150647
In short: On July 9, 2010, FDA issued a Form 483 with 12 observations to Johnson and Johnson (McNeil) in Lancaster, Pennsylvania (FEI 1000150647) after an inspection that ran Jun 22 – Jul 9, 2010. The investigators were Anita R. Michael and Sharon K. Thoma. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Quality system and laboratory controls account for 8 of 12 observations.
Most cited: 21 CFR 211.160 (3×) · 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
Records associated with drug product production and control and within the retention period for such records…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Written records of investigations into unexplained discrepancies do not always include…
- 04
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Anita R. Michael
18 documents · 2006–2020
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmJohnson and Johnson (McNeil) history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Johnson and Johnson (McNeil)?
FDA listed 12 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Johnson and Johnson (McNeil)?
Anita R. Michael and Sharon K. Thoma are named on this Form 483, for the inspection of Jun 22 – Jul 9, 2010. Each investigator has a profile showing what they cite most.
When was Johnson and Johnson (McNeil) inspected by FDA?
The inspection ran Jun 22 – Jul 9, 2010, and the Form 483 is dated July 9, 2010.
How do I get the full Form 483 for Johnson and Johnson (McNeil)?
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.