Ameridose, LLC
Form 483 issued August 6, 2008 · Framingham, Massachusetts
- Inspection
- Jul 23, 2008
- Investigator
- Richard H. Penta
- Observations
- 6
- Pages
- 4
- FEI number
- 3005881167
In short: On August 6, 2008, FDA issued a Form 483 with 6 observations to Ameridose, LLC in Framingham, Massachusetts (FEI 3005881167) after an inspection that ran Jul 23, 2008. The investigator was Richard H. Penta. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
4 of 6 observations on this 483 concern production.
Most cited: 21 CFR 211.188 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Written procedures are lacking which describe in sufficient detail the identification, sampling, testing, approval…
- 03
The master production and control records are deficient in that they do not include a statement…
- 04
Batch production and control records do not include results of the inspection of the packaging and…
This inspection in context
Richard H. Penta
4 documents · 2007–2008
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in Massachusetts.
The firmAmeridose, LLC history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ameridose, LLC?
FDA listed 6 observations on this Form 483, mostly about production, laboratory controls and materials. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Ameridose, LLC?
Richard H. Penta is named on this Form 483, for the inspection of Jul 23, 2008. Each investigator has a profile showing what they cite most.
When was Ameridose, LLC inspected by FDA?
The inspection ran Jul 23, 2008, and the Form 483 is dated August 6, 2008.
How do I get the full Form 483 for Ameridose, 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.