Home Care Pharmacy of Palm Coast Inc.
FDA inspection history in Palm Coast, Florida, 2016 to 2020
- 2
- Form 483s
- 1
- Untitled letter
- 1
- Warning letter
Every document, by year
- Untitled letter
- Form 483
- Warning letter
2016: one Form 483; 2017: one warning letter; 2018: one Form 483; 2020: one untitled letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–20Two Form 483s, one warning letter and one untitled letter, at Palm Coast, Florida.
- 2016The longest 483 on file: 7 observations over 5 pages at Palm Coast, Florida.
Cited most
Across all Home Care Pharmacy of Palm Coast observations on file
- 21 CFR 211.42(c)(10)(iii)Design and construction features3
- FDCA 501(a)(2)(A)Insanitary conditions3
- 21 CFR 211.167(a)Special testing requirements1
- 21 CFR 211.188(b)Batch production and control records1
- 21 CFR 211.192Production record review1
The complete Home Care Pharmacy of Palm Coast file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Palm Coast, Florida
Two Form 483s, one untitled letter and one warning letter · 2016 to 2020 · 10 observations
Latest: Untitled letter, May 4, 2020 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-05-04 | Untitled letter Untitled letter | Palm Coast, Florida | — | $99 |
| 2018-04-25 | 483 Form 483 | Palm Coast, Florida | 3 | $99 |
| 2017-08-31 | Warning letter Warning letter | Palm Coast, Florida | — | $99 |
| 2016-06-17 | 483 Form 483 | Palm Coast, Florida | 7 | $99 |
Investigators on these documents
FEI number 3006899675 · most recent document May 4, 2020
About Home Care Pharmacy of Palm Coast Inc.
How many FDA Form 483s has Home Care Pharmacy of Palm Coast Inc. received?
FDA Intel has 2 Form 483s on file for Home Care Pharmacy of Palm Coast Inc.; the most recent is dated Apr 25, 2018.
When was Home Care Pharmacy of Palm Coast Inc. last inspected by FDA?
The most recent FDA inspection document on file for Home Care Pharmacy of Palm Coast Inc. is a Form 483 dated Apr 25, 2018, for the site in Palm Coast, Florida.
What did FDA cite at Home Care Pharmacy of Palm Coast Inc.?
The regulations cited most in the observations on file for Home Care Pharmacy of Palm Coast Inc. are 21 CFR 211.42(c)(10)(iii) (Design and construction features), 3 times; FDCA 501(a)(2)(A) (Insanitary conditions), 3 times; 21 CFR 211.167(a) (Special testing requirements), 1 time.
Has Home Care Pharmacy of Palm Coast Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Home Care Pharmacy of Palm Coast Inc.; the most recent is dated Aug 31, 2017.
Has Home Care Pharmacy of Palm Coast Inc. received an FDA untitled letter?
Yes. FDA Intel has 1 FDA untitled letter on file for Home Care Pharmacy of Palm Coast Inc.; the most recent is dated May 4, 2020. An untitled letter is FDA's enforcement letter for violations that don't rise to warning-letter level.