Violation Code: 27
FDA Violation
Charge Code: DRUG GMPS
Violation Details
- Violation Code (ASC ID)
- 27
- Charge Code
- DRUG GMPS
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
- Legal Section
- 501(a)(2)(B), 801(a)(3); ADULTERATION
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/29/2025 | PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. 55YP99 | Opto-Pharm Pte Ltd.SINGAPORE |
| 12/29/2025 | CLOPIDOGREL BISULFATE (ANTI-COAGULANT) 61LDC38 | |
| 12/29/2025 | ANTIFUNGAL N.E.C. 56GAC99 | |
| 12/22/2025 | ANTI-HYPERTENSIVE N.E.C. 62CDA99 | |
| 12/19/2025 | FLUOXETINE (ANTI-DEPRESSANT) 61NDY29 | |
| 12/19/2025 | ARIPIPRAZOLE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) 66NDY06 | |
| 12/19/2025 | ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. 66PAY99 | Kolmar Korea Co. Ltd.SOUTH KORE |
| 12/19/2025 | LEVONORGESTREL (ESTROGEN) 64GDA29 | |
| 12/12/2025 | LEVOCARNITINE (NUTRIENT/TONIC) 65CDY07 | |
| 12/8/2025 | ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS) 54FGF94 | |
| 12/5/2025 | GUAIFENESIN (EXPECTORANT) 64HDY02 | |
| 11/25/2025 | TOBRAMYCIN (ANTI-MICROBIAL) 62HDY02 | |
| 11/25/2025 | CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT 64DDY01 | |
| 11/19/2025 | HOMEOPATHIC ANALGESIC 66XBL01 | |
| 11/19/2025 | HOMEOPATHIC ANALGESIC 66XBL01 |
Related Violations
Other violations under the same legal section: 501(a)(2)(B), 801(a)(3); ADULTERATION
Frequently Asked Questions
What is FDA violation code 27?
27 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).". This violation is based on 501(a)(2)(B), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 27?
According to FDA Import Refusal data, there have been 3954 import refusals issued for violation code 27, affecting 834 unique firms.
When was the most recent refusal for violation 27?
The most recent import refusal for violation 27 was on December 29, 2025.
What products are commonly refused for violation 27?
Products commonly refused under violation 27 include: PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C., CLOPIDOGREL BISULFATE (ANTI-COAGULANT), ANTIFUNGAL N.E.C., ANTI-HYPERTENSIVE N.E.C., FLUOXETINE (ANTI-DEPRESSANT). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 27?
Violation code 27 is based on 501(a)(2)(B), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section of the law establishes requirements that imported products must meet to be allowed entry into the United States.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.