Sancilio & Company, Inc.
Form 483 issued January 20, 2017 · Riviera Beach, Florida
- Inspection
- Jan 9 – Jan 20, 2017
- Investigators
- Ileana Barreto-Pettit· Ivis L. Negron Torres· Jennifer L. Huntington
- Observations
- 8
- Pages
- 13
- FEI number
- 2000027140
In short: On January 20, 2017, FDA issued a Form 483 with 8 observations to Sancilio & Company, Inc. in Riviera Beach, Florida (FEI 2000027140) after an inspection that ran Jan 9 – Jan 20, 2017. The investigators were Ileana Barreto-Pettit, Ivis L. Negron Torres, Jennifer L. Huntington and Jingbo Xiao. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and facilities & equipment account for 7 of 8 observations.
Most cited: 21 CFR 211.166 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
The written stability program for dmg products does not include reliable, meaningful…
- 03
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 04
Backup data is not assured as exact, complete and secure from alteration, erasure or loss through…
This inspection in context
Ileana Barreto-Pettit
25 documents · 2001–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmSancilio & Company, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sancilio & Company, Inc.?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Sancilio & Company, Inc.?
Ileana Barreto-Pettit, Ivis L. Negron Torres, Jennifer L. Huntington and Jingbo Xiao are named on this Form 483, for the inspection of Jan 9 – Jan 20, 2017. Each investigator has a profile showing what they cite most.
When was Sancilio & Company, Inc. inspected by FDA?
The inspection ran Jan 9 – Jan 20, 2017, and the Form 483 is dated January 20, 2017.
How do I get the full Form 483 for Sancilio & Company, Inc.?
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.