Manufacturers - 1
needs to obtain a permit, he can continue to manufacture, process or pack product, although the product cannot be introduced or delivered for introduction into interstate commerce unless the firm obtains FDA's advance written approval. We do not give such approval until the processor provides an evaluation of the potential public health significance, of each code lot, conducted by a competent authority in accordance with procedures recognized as being adequate to detect any potential public health hazard. The processor can ship product interstate to a consolidation warehouse or other storage facility which is under their control.
§108.7 - Issuance or denial of permit.
The processor must apply to FDA for issuance of a permit. The application must contain sufficient information and data to show that all mandatory requirements and conditions of the regulations are met, and that the deviations specified in the order of determination of need for a permit have been corrected or suitable interim measures have been established. All mandatory conditions and requirements must be documented as being in compliance, not just the deviations pointed out in the order.
The processor can supply photos, diagrams, records, etc. to document compliance. Some of the requirements of the regulations are procedural in nature and cannot be documented. After CFSAN receives this documentation, a thorough inspection must be conducted to determine whether the processor is in full compliance. Depending on the results of the inspection, FDA will either issue or deny a permit. Denial triggers a hearing.
FDA can attach to the permit, in addition to the mandatory requirements and conditions of the regulations, any additional requirements or conditions which may be necessary to protect public health. For example, in a few cases FDA has required that the processor hire a qualified quality control manager and prepare a standard operating procedure manual. These additional conditions are referenced in the order of need letter.
Once a processor has received a permit he operates in a normal fashion, i.e., he can distribute product without FDA approval. However, the compliance program requires FDA inspection once or twice a year to monitor the firm's compliance status. These inspections should be thorough and should concentrate on areas previously found to be out of compliance.
§108.10 - Suspension and reinstatement of permit.
When an inspection reveals that a permit holder is not in compliance with the mandatory requirements and conditions established by the permit, FDA can suspend the permit. This places the firm back under the order of determination of the need for a permit. The firm may apply for reinstatement the same way they applied for a permit. An inspection is usually conducted before a decision to reinstate is made. The processor can request a hearing at which time FDA will determine whether the permit is reinstated or suspended. Denial of reinstatement is a final agency decision from which appeal lies to the courts.
§108.6 Revocation of determination of need for permit.
A permit is required only for a temporary period (that which is necessary to protect public health). When FDA believes the permit holder is in compliance with the mandatory requirements and conditions of the regulations and is likely to remain in compliance, FDA can, on its' own initiative, or upon application of the permit holder, revoke both the determination of need for a permit and the permit which was issued. If we deny the permit holders application, the permit holder can request a hearing. The decision as to what point of time a permit holder is "likely to remain in compliance" is very subjective and based on the particular situation and the results of inspections conducted after the permit was issued. Generally, several inspections over a one or two year period, showing compliance with the regulations would be sufficient to demonstrate the likelihood that the processor will remain in compliance. Therefore, inspections performed should be thorough.
The revocation of the determination of need for a permit, and the permit, does not preclude initiation of further permit proceedings in the future if later information shows that the need for a permit exists.
§108.19 - Establishment of requirements for exemption from section 404 of the act.
This section restates part of Section 404, and that the FDA or a petitioner may propose regulations to be included in Subpart B. It also states processors are exempt from the requirement to obtain a permit only if they meet the requirements of regulations contained in Subpart B.
The two classes of food for which regulations have been issued are acidified foods (§108.25) and low-acid canned foods (§108.35).
Sections 108.25(a) and 108.35(a) require