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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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SEI Pharmaceuticals, Inc. 3/26/12

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Florida District
555 Winderley Place, Suite 200
Maitland; Florida 32751
Telephone: 407-475-4700
FAX: 407-475-4770

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-12-28

March 26, 2012

 

Mr. Harold Miller
Owner
SEI Pharmaceuticals, Inc.
3553 NW 50th St
Miami, FL 33142-3931

Dear·Mr. Miller:

During the period from September 19, 2011 to September 29, 2011, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 3553 NW 50th St, Miami, Florida. Our investigation revealed significant violations of FDA's Current Good Manufacturing Practice (CGMP) regulations in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the dietary supplements manufactured in your facility to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that these dietary supplements have been prepared, packed, or held under conditions that do not meet current good manufacturing practice requirements for dietary supplements. You may find the Act and its implementing regulations through links on FDA's home page at www.fda.gov.

We received your written response dated October 21, 2011 to the FDA-483 presented to you at the conclusion of the inspection, on November 1, 2011. Our comments regarding the adequacy of the actions you took to correct the violations observed during the inspection are detailed after each violation that is noted below.

The inspection revealed the following violations:

1. Your firm failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Our investigator found:d that your standard operating procedures for quality assurance do not address these functions.

We have reviewed your response dated October 21, 2011, indicating that SEI Pharma will establish and implement written procedures for quality control operations. However, your response is inadequate because you did not provide any supporting documentation of a corrective action.

2. Your firm failed to verify that your finished batch of dietary supplements met established product specifications for identity, purity, strength, composition, and for limits on types of contamination that adulterate or lead to adulteration of the finished batch, as required by 21 CFR 111.75(c). You must establish product specifications for each dietary supplement you manufacture (21 CFR 111.70(e)), and determine whether these specifications are met (21 CFR 111.73) by testing the finished batch of dietary supplements in accordance with testing requirements in 21 CFR 111.7 5( c).

We have reviewed your response dated October 21, 2011, indicating that SEI Pharma will implement testing procedures for finished products. However, your response is inadequate because you did not provide any supporting documentation of a corrective action.

3. Your firm failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of a dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a).

We have reviewed your response dated October 21, 2011, indicating that SEI Pharma will create master manufacturing records for each of its unique formulations of each dietary supplement manufactured at SEI Pharmaceuticals. However, your response is inadequate because you did not provide any supporting documentation of a corrective action.

4. Your firm failed to prepare a batch production record every time you manufactured a batch of dietary supplement, as required by 21 CFR 111.255(a).

We have reviewed your response dated October 21, 2011, indicating that SEI Pharma will identify and implement the requirem.ents for batch production records for each dietary supplement manufactured at SEI Pharma. However, your response is inadequate because you did not provide any supporting documentation of a corrective action.

5. Your firm failed to establish written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met, as required by 21 CFR 111.303.

We have reviewed your response dated October 21, 2011, indicating that SEI Pharma will establish and implement specifications, examination, and testing procedures for applicable components and finished products. However, your response is inadequate because you did not provide any supporting documentation of a corrective action.

6. You did not maintain, clean, and sanitize, as necessary, all equipment, utensils, and contact surfaces used to manufacture, package, label, or hold components or dietary supplements, as required by 21 CFR 111.27(d). Specifically, on 9/28/11, our investigator observed funnels and metal and plastic chutes, all with residue leftover after cleaning was completed.

We have reviewed your response dated October 21, 2011, indicating that SEI Pharma will establish and implement sanitation procedures and train employees and records will be kept to document maintenance and cleaning. However, your response is inadequate because you did not provide any supporting documentation a corrective action, including documentation of a corrective action with respect to the funnels and chutes.

7. Your firm failed to establish written procedures for packaging and labeling operations, as required by 21 CFR 111.403.

We have reviewed your response dated October 21, 2011, indicating that SEI Pharma will establish and implement procedures for labeling operations. However, your response is inadequate because you did not provide any supporting documentation of a corrective action.

8. Your firm did not establish any written procedures for holding and distributing operations, as required by 21 CFR 111.453.

We have reviewed your response dated October 21, 2011, indicating that SEI Pharma will establish and implement procedures for holding and distributing operations.

However, your response is inadequate because you did not provide any supporting documentation of a corrective action.

9. You did not establish written procedures for when a returned dietary supplement is received, as required, by 21 CFR 111.503.

We have reviewed your response dated October 21, 2011, indicating that SEI Pharma will establish and implement procedures for when a returned dietary supplement is received. However, your response is inadequate because you did not provide any supporting documentation of a corrective action.

This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment and the products you manufacture or distribute comply with the Act and its implementing regulations.

Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and/or distributors of violative products.

Please notify this office in writing within 15 working days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not recur. Your response should include any documentation necessary to show that correction has been achieved. If any corrective action cannot be completed before you respond, explain the reason for the delay and the date by which you will complete the corrections.

Your response should be sent to: Winston R. Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751. If you have any questions about the content of this letter please contact: Mr. Alejo at (407) 475-4731.

Sincerely,

/s/

Emma R. Singleton
Director, Florida District