Johnson and Johnson (McNeil)
Amended 483 issued March 27, 2015 · Lancaster, Pennsylvania
- Inspection
- Mar 17 – Mar 27, 2015
- Investigators
- James M. Mason· Rabin N. Ghoshal· Thomas E. Friel
- Observations
- 2
- Pages
- 3
- FEI number
- 1000150647
In short: On March 27, 2015, FDA issued a Amended 483 with 2 observations to Johnson and Johnson (McNeil) in Lancaster, Pennsylvania (FEI 1000150647) after an inspection that ran Mar 17 – Mar 27, 2015. The investigators were James M. Mason, Rabin N. Ghoshal and Thomas E. Friel. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.110(a) (1×) · 211.22(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
The quality control unit lacks authority to fully investigate…
The full amended 483
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
James M. Mason
13 documents · 2011–2020
Cites 211.113 (control of microbiological contamination) 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 documentsOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Johnson and Johnson (McNeil)?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Johnson and Johnson (McNeil)?
James M. Mason, Rabin N. Ghoshal and Thomas E. Friel are named on this Amended 483, for the inspection of Mar 17 – Mar 27, 2015. Each investigator has a profile showing what they cite most.
When was Johnson and Johnson (McNeil) inspected by FDA?
The inspection ran Mar 17 – Mar 27, 2015, and the Amended 483 is dated March 27, 2015.
How do I get the full Amended 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.